510(k) · Cleared

Cleared

MSS-28CS-301/701 Needlescope

K013759510(k) TraditionalCleared Aug 20, 2002280-day reviewClass II21 CFR 882.1480

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Olympus Optical Co., Ltd. · GWG Endoscope, Neurological

Cleared on Aug 20, 2002 as substantially equivalent to K971340 (Olympus Optical, Co., 1998) after a 280-day review. Its family tree reaches back 2 generations to 1993.

Decided: Aug 20, 2002
Review: 280 days
Class: Class II
Product code: GWG
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K923555 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK923555 Codman Gaab NeuroendoscopeCodman & Shurtleff, Inc. · 1993
1 generation backK971340 Olympus Neuro EndoscopeOlympus Optical, Co. · 1998
This deviceK013759 MSS-28CS-301/701 NeedlescopeOlympus Optical Co., Ltd. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K923555	Codman Gaab Neuroendoscope	Codman & Shurtleff, Inc.	1993	—
−1	K971340	Olympus Neuro Endoscope	Olympus Optical, Co.	1998	—
0 (this device)	K013759	MSS-28CS-301/701 Needlescope	Olympus Optical Co., Ltd.	2002	—

FIG. 1 — Lineage of K013759, 1993–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GWG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GWG device

#1 K211202 1688 4K Camera System, L11 LED Light Source…score 22.5 · 20 generations · no Class I recall
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K971340	Olympus Neuro Endoscope Our reading of the summary gave K973140, FDA’s number for Duet Glucose Control Monitoring System (Lxn Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Olympus Neuro Endoscope A7595”.	Olympus Optical, Co.	1998	—
Kept off the family tree	K993568	FDA’s K993568 is Machida Flexible Neuro-Endoscope, Models Neu-4, Neu-4L Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Machida Endoscope Co., Ltd.	2000	—

Also cleared against K971340: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate K971340.

How does its category compare?

All GWG devices

GWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWG

2in 2025

2007high 5 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWG

269in 2023

2007high 269 (2023) · low 106 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GWG

2in 2011

2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GWG

33in 2025

2007high 37 (2015) · low 0 (2009)2025

MAUDE reports naming product code GWG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	3
2008	2	—	0	5
2009	0	—	1	0
2010	0	—	0	1
2011	0	—	2	4
2012	0	—	0	7
2013	1	—	0	3
2014	2	—	0	19
2015	0	—	0	37
2016	2	—	0	25
2017	4	126	0	12
2018	4	128	0	16
2019	3	156	0	10
2020	2	—	0	19
2021	3	106	0	21
2022	0	—	0	12
2023	5	269	0	9
2024	1	—	0	9
2025	2	—	0	33
2026	4	217	0	—

What is it indicated for?

OLYMPUS NEEDLESCOPE MSS-Z8CS-301/701 has been designed-to be combined with the OPERATION MICROSCOPE OME-8000 for use in observation of the brain ventrides/ , and the brain parenchyma, in confirmation of clips on cerebral aneurysms, and for performing diagnostic procedures, such as observation of cerebrat aneurysms, observatiorr of cerebral tissues including brairr tumors, observation of cerebral vascular systems and cranial nerves, and observation-of hypophysis tumors.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K013759 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013759: MSS-28CS-301/701 Needlescope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013759

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026